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Completed

NCT Number: NCT00679198

Improving Osteoporosis Care in High-Risk Home Health Patients

SPECIFIC AIMS: We propose a three-year study to develop a high-intensity intervention to improve osteoporosis care and test a novel intervention in a group-randomized trial of 27 home health offices and 1,000 patients referred to home health care with a history of fracture.

Aim 1. Develop an intervention to promote osteoporosis treatment that includes: (1) training to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and fracture risk; (2) automated prompts within the home health agency's electronic medical record system to promote appropriate osteoporosis management; and (3) implementation of osteoporosis-related standardized care pathways and order sets.

Aim 2. Conduct a group-randomized trial to test the effectiveness of the intervention to promote initial use of osteoporosis medications and adherence to treatment after discharge from home health. We hypothesize that:

H1: Patients in the intervention group will have increased initial receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis compared to patients receiving usual care; H2: Patients in the intervention group will demonstrate increased persistence in the use of these therapies compared to those receiving usual care.

Secondary Aims (SA) will include exploratory analyses of fracture related morbidity and mortality, patient-reported quality of life, and health services utilization and costs.

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Key information

Conditions

Patient Compliance Behavior Bone Diseases Bone Diseases, Metabolic Communication Fractures, Bone Health Behavior Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Patient Acceptance of Health Care Treatment Adherence and Compliance Wounds and Injuries

Age range

Up to 95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham Department of Rheumatology

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will be identified as "at-risk" if they are referred to home health care for post-fracture care or if they are admitted for another reason and have a previous diagnosis of fracture.

Exclusion criteria

  • Patients in hospice, with a life expectancy < 1 year, over 95 years old, or with concomitant metabolic bone diseases (e.g. Paget's disease of bone) will be excluded.

Treatment and study plan

nurse-patient communication

Behavioral

We will train home health nurses to act as patient advocates by communicating the risks and benefits of osteoporosis treatment to patients and their healthcare providers.

Thus, we will provide a comprehensive, integrated approach to the management of osteoporosis among patients with a history of insufficiency fractures that is highly generalizable to a national setting.

Primary outcomes

  1. Increased receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis

    Time frame: within 3 months of discharge from home health care

Secondary outcomes

  1. Increased persistence in the use of these therapies

    Time frame: 18 months after their discharge from home health care

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Alacare Home Health and Hospice

Registry information

Official study title

Improving Osteoporosis Care in High-Risk Home Health Patients Through a High-Intensity Intervention

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
May 16, 2008
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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